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Human-derived whole-blood matrix quality control product for portable glucometer

A technology of quality control products and blood glucose meters, which is applied in the preparation of test samples, instruments, scientific instruments, etc., can solve hidden dangers in the management and treatment of diabetic patients, the cost of supporting calibration products or quality control products, and the existence of actual results Differences and other issues, to achieve the value of large market promotion and application, to meet the requirements of quality control, and to achieve the effect of low cost

Inactive Publication Date: 2019-03-26
北京市临床检验中心 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, most of the blood glucose calibration products or quality control products used to verify the precision, stability and accuracy of the blood glucose meter are non-human whole blood matrix, while the portable blood glucose meter mainly detects glucose in human whole blood, and uses non-human The test results obtained by using whole blood matrix as a quality control product will be different from the actual results; secondly, different brands of blood glucose meters have different quality control products, and even different models of blood glucose meters of the same brand also have different quality control products. The same quality control product measured on different brands of instruments will have different results, and the target value will also be different when measured on the same brand of different models of instruments, indicating that the test results of quality control products cannot be interoperable.
Not only that, the supporting calibrators or quality control products provided by the manufacturer are expensive, and some imported reagents are also limited by transportation conditions and supply chains
This not only increases medical costs, but also lays hidden dangers for the management and treatment of diabetic patients

Method used

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  • Human-derived whole-blood matrix quality control product for portable glucometer
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  • Human-derived whole-blood matrix quality control product for portable glucometer

Examples

Experimental program
Comparison scheme
Effect test

experiment example 1

[0038] Experimental Example 1. The present invention is used in the homogeneity verification of human whole blood matrix quality control products for portable blood glucose meters

[0039] Referring to the CNAS-GL29 standard issued by the China National Accreditation Service for Conformity Assessment - "General Principles and Statistical Methods for Valuation of Standard Materials / Standard Samples" on the evaluation of uniformity research, use HORIBA glucose electrode analyzer (LP-150C ) were tested, and 10 samples (No. 1-10) were randomly selected from the quality control products of each blood glucose concentration (low, medium, high) as samples for uniformity evaluation, and each sample was repeatedly measured 3 times. The order of the first determination in the measurement process is: 1-3-5-7-9-2-4-6-8-10; the order of the second determination is: 10-9-8-7-6-5 -4-3-2-1; the order of the third measurement is: 2-4-6-8-10-1-3-5-7-9, the results are shown in Table 1. Statisti...

experiment example 2

[0056] Experimental example 2. Stability verification of human whole blood matrix quality control products used in portable blood glucose meters according to the present invention

[0057] With reference to the CNAS-GL29 standard issued by the China National Accreditation Service for Conformity Assessment——"General Principles and Statistical Methods for Valuation of Standard Materials / Standard Samples" about the stability evaluation requirements for the human-derived whole blood matrix quality control product of the present invention for a short-term 2 Stability evaluation at -8°C. Randomly select 3 quality control substances for each blood glucose concentration (low, medium, high) as samples, repeat the measurement twice for each sample, and complete each measurement within 10 minutes, then immediately store the remaining samples at 2-8°C. Use the HORIBA glucose electrode analyzer (LP-150C) to measure continuously for 20 days, and observe the difference between the results of...

experiment example 3

[0072] Experimental Example 3: Interoperability Verification of Human Whole Blood Matrix Quality Control Products Used in Portable Blood Glucose Meters in the Present Invention

[0073] Collect 33 clinical samples with blood glucose concentrations in the high, medium and low concentration ranges, and use different brands and models of blood glucose meters and large-scale biochemical analysis in the central laboratory for the samples and the quality controls of the three blood glucose concentrations that need to be verified. The blood glucose meter (HITACHI 7600) was tested, and the two sets of data were linearly regressed to draw the 95% confidence interval of the blood glucose meter detection method for the central laboratory detection method, and judge whether the measured value of the quality control product fell within the 95% confidence interval. If the measured value falls within the 95% confidence interval, it indicates that the interoperability is good; if it does not f...

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Abstract

The invention discloses a human-derived whole-blood matrix quality control product for a portable glucometer. The quality control product is a human-derived product and is prepared from raw materialsincluding human whole blood and a fixing agent; a preparation process comprises the following steps: separating whole blood cells from the human whole blood; fixing the whole blood cells through the fixing agent to obtain a fixed matter; and preparing quality control products with high, middle and low blood glucose concentrations by utilizing the fixed matter. The quality control products with high, middle and low blood glucose concentration levels are utilized, and errors which possibly exist in the detection of the high, middle and low blood glucose concentrations on a medical blood glucosedetermination value level of the portable glucometer can be effectively detected in time. According to the quality control product disclosed by the invention, the human whole blood cells are fixed, sothat on one hand, the quality control product is a whole blood matrix and is consistent to a specimen type identified trough the glucometer; and on the other hand, the problem that blood glucose hasa glycolysis effect in the blood is also solved and the numerical value of the blood glucose is stabilized. The quality control product disclosed by the invention has good intercommunity and is also applicable to various portable glucometers with different brands and different models.

Description

technical field [0001] The present invention relates to the technical field of standard products used in the clinical testing process, in particular to a human source whole blood matrix quality control product for portable blood glucose meters, especially suitable for human sources of various blood glucose meters of different brands or models Whole blood matrix quality control. Background technique [0002] Today, POCT (point-of-care testing, point-of-care testing) technology is more and more favored by clinicians due to its advantages of bedside detection such as rapidity, simplicity, small sample volume, and potential improvement of patient prognosis. As the most frequently used POCT instrument in medical institutions, the accuracy and reliability of portable blood glucose meters play a vital role in the monitoring and management of patients' blood glucose in medical institutions. [0003] However, due to the lack of effective reference materials (reference materials, RMs...

Claims

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Application Information

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IPC IPC(8): G01N33/66G01N1/30
CPCG01N1/30G01N33/66G01N2001/2893G01N2001/305
Inventor 王清涛周睿王艳张顺利
Owner 北京市临床检验中心